Journal List > Korean J Lab Med > v.28(2) > 1011460

Hwang, Oh, Choi, Kim, Chang, Lee, and Son: Meta-Analysis for the Pooled Sensitivity and Specificity of Hepatitis B Surface Antigen Rapid Tests

Abstract

Background

Although hepatitis B surface antigen (HBsAg) rapid test based on immunochromatographic assay (ICA) is now widely used, the test has not been evaluated sufficiently enough to validate its performance. Thus, it is important to summarize the clinical performance of the test kits. In this study, we performed meta-analysis for the performance of the HBsAg rapid tests.

Methods

PubMed database was searched using keywords about the accuracy of diagnostic tests for hepatitis B virus (HBV) infection. Two investigators assessed methodological quality utilizing standards for reporting of diagnostic accuracy studies (STARD) checklist. After performing a heterogeneity test, we obtained pooled sensitivity and specificity. Positive and negative predictive values (PPV and NPV) were simulated according to HBV prevalence.

Results

A total of 38 studies was selected from 10 papers. The quality scores ranged from 3 to 13 (median, 8). Kappa value was good (0.85). The performance of the 38 studies was heterogeneous. When 33 studies with better quality from 7 papers were re-selected, the pooled sensitivity and specificity were 98.07% (95% confidence interval, CI: 97.67-98.47%) and 99.56% (95% CI: 99.21-99.91%), respectively. With an HBV prevalence of 5%, PPV and NPV were predicted to be 92.14% and 99.90%, respectively.

Conclusions

In view of high HBV prevalence in Korea, it is thought that the HBsAg rapid test can be used for HBV screening in small-sized laboratories or for epidemiologic studies. This study should be helpful in establishing a guideline for the proper performance evaluation of the HBsAg rapid tests.

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Fig. 1.
Funnel plots for publication bias of sensitivities (A), and specificities (B).
kjlm-28-160f1.tif
Fig. 2.
Estimates of sensitivity and specificity of HBsAg rapid tests. Points indicate estimates of sensitivities (A) and specificities (B). Vertical lines are 95% confidence intervals for estimates.
kjlm-28-160f2.tif
Fig. 3.
Predictive values according to prevalence with pooled sensitivity (98.07%) and specificity (99.56%). The Y axis plot positive predictive value (PPV) (A), and negative predictive value (NPV) (B).
kjlm-28-160f3.tif
Table 1.
Literature survey on both sensitivity and specificity of HBsAg rapid test kits
Studies References Spectrum of patients Reference standard Test assay TP FN FP TN Sn Sp
Clement [16] 403 patients with biopsy-proven chronic HBV infection, 295 healthy volunteers MEIA Binax NOW 402 1 2 293 99.8 99.3
WHO (1) [12] 99 HBsAg positive, 178 HBsAg negative sera from patients ELISA Genedia HBsAg Rapid 98 1 0 277 99.0 100
WHO (2)       Doublecheck HBs Antigen 98 1 7 171 99.0 96.1
WHO (3)       Genelabs Diagnostics Rapid HBsAg test 98 1 5 173 99.0 97.2
WHO (4)       Hepacard HBsAg 98 1 4 174 99.0 97.8
WHO (5)       ImmunoComb II HBs Ag 90 98 1 8 170 99.0 95.5
WHO (6)       Serodia HBs 98 1 0 178 99.0 100
WHO (7)       Determine HBsAg 98 1 1 177 99.0 99.4
WHO (8)       Uni-Gold HBsAg 98 1 0 178 99.0 100
WHO (9)       HEP B STAT-PAK ULTRA FAST 98 1 0 178 99.0 100
Lien (1) [17] 101 HBsAg seroreactive, EIA Determine HBsAg 117 0 0 211 100 100
Lien (2)   99 HBsAb seronegative, EIA Serodia HBs 112 5 0 211 95.7 100
Lien (3)   128 potential cross-reactive group EIA Dainascreen HBsAg 117 0 0 211 100 100
Akanmu [18] 101 blood donors ELISA Binax NOW 7 1 0 93 87.5 100
Lau [19] 2463 selected samples (827 frozen sera, 1011 fresh sera, and 625 whole blood samples) EIA Binax NOW 157 8 0 2,298 95.2 100
Sato [20] 462 routine samples a representation of worldwide genotypes EIA and RPHA Dainascreen HBsAg 158 0 0 304 100 100
ICBS (1) [13]   EIA Determine HBsAg 143 3 0 200 98.0 100
ICBS (2)       HBsAg Line test 143 3 0 200 98.0 100
ICBS (3)   A, B, C, D, E, F and their corresponding variety of subtypes.   Acon HBsAg One Step 143 3 0 200 98.0 100
ICBS (4)       HBsAg Dipstick One Step test 142 4 0 200 97.3 100
ICBS (5)   This HBV positive panel is composed of: a) 146 individual HBsAg positive members, b) 200 individual non-infectious plasma units received from the American Red Cross in Washington D.C., U.S.A   HBsAg 143 3 0 200 98.0 100
ICBS (6)       HbsAg Cassette 142 4 0 200 97.3 100
ICBS (7)       Quick HBsAg test 142 4 0 200 97.3 100
ICBS (8)       Assure HBsAg rapid test 143 3 0 200 98.0 100
ICBS (9)       i+LAB HBsAG test 142 4 0 200 97.3 100
ICBS (10)       Quick Chaser HBsAg 143 3 0 200 98.0 100
ICBS (11)       One Step HBsAg Dipstick test 143 3 0 200 98.0 100
ICBS (12)       BioLine HBsAg Strip 143 3 0 200 98.0 100
ICBS (13)       SD BioLine HBsAg 143 3 0 200 98.0 100
ICBS (14)       HEP-CHECK-1 138 8 0 200 94.5 100
ICBS (15)       HEP-CHECK-1-STRIP 142 4 0 200 97.3 100
ICBS (16)       HepaScan HBsAg cassette type/HepaScan HBsAg strip type 143 3 0 200 98.0 100
Cha (1) [7] 20 HBsAg-positive, 20 HBsAg-negative sera by MEIA MEIA SD BioLine HBsAg 13 7 0 20 65.0 100
Cha (2)       Asan Easy Test HBsAg 16 4 0 20 80.0 100
Cha (3)       Genedia HBsAg Rapid 17 3 0 20 85.0 100
Oh [5] 150 HBsAg-positive, 100 HBsAg-negative sera by EIA EIA Genedia HBsAg Rapid 147 3 0 100 98.0 100
Whang (1) [6] 100 HBsAg-positive, 100 HBsAg-negative sera by MEIA MEIA Daewoong rapid HBsAg 97 3 0 100 97.0 100
Whang (2)       Genedia HBsAg Rapid 97 3 0 100 97.0 100

Abbreviations: TP, true positive; FN, false negative; FP, false positive; TN, true negative; Sn, sensitivity; Sp, specificity; MEIA, microparticle enzyme immunoassay; EIA, enzyme immunoassay; RPHA, reverse passive hemagglutination assay.

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